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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06979375




Registration number
NCT06979375
Ethics application status
Date submitted
15/05/2025
Date registered
19/05/2025
Date last updated
19/05/2025

Titles & IDs
Public title
A Research Study Comparing CDR132L With Placebo on the Structure and Function of the Heart in People With Heart Failure With Reduced/Mildly Reduced Ejection Fraction and Left Ventricular Hypertrophy
Scientific title
Phase 2, Multicentre, Randomised, Double-blind, Placebo-controlled Safety and Efficacy Study of CDR132L on Reverse Cardiac Remodelling in Participants With Heart Failure With Reduced/Mildly Reduced Ejection Fraction and Left Ventricular Hypertrophy
Secondary ID [1] 0 0
U1111-1313-4591
Secondary ID [2] 0 0
NN6706-8282
Universal Trial Number (UTN)
Trial acronym
8282-Reduced
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - CDR132L
Treatment: Drugs - Placebo

Experimental: CDR132L + SoC - Participants will receive intravenous infusion of CDR132L once every 4 weeks for 48 weeks. Participants will also continue their individually adapted guideline-directed Standard of care (SoC) therapy for heart failure.

Placebo comparator: Placebo + SoC - Participants will receive intravenous infusion of placebo once every 4 weeks for 48 weeks. Participants will also continue their individually adapted guideline-directed Standard of care (SoC) therapy for heart failure.


Treatment: Drugs: CDR132L
Administered intravenous infusion of CDR132L once every 4 weeks for 48 weeks.

Treatment: Drugs: Placebo
Administered intravenous infusion of placebo once every 4 weeks for 48 weeks.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Main Phase: Change in microRNA-132-3p (miR-132)
Timepoint [1] 0 0
From baseline to week 24
Secondary outcome [1] 0 0
Main Phase: Change in composite Z-score based on the 3 outcome measures: LVEDVi; LVESVi; NT-proBNP
Timepoint [1] 0 0
From baseline to week 24
Secondary outcome [2] 0 0
Main Phase: Number of adverse events
Timepoint [2] 0 0
From baseline to week 24
Secondary outcome [3] 0 0
Extension Phase: Number of adverse events
Timepoint [3] 0 0
From baseline to week 60

Eligibility
Key inclusion criteria
* Age 40-84 years (both inclusive) at the time of signing the informed consent.
* Documented symptomatic heart failure (HF) diagnosed greater than or equal to (=) 180 days prior to screening with at least weekly need for oral diuretic treatment, and New York Heart Association class II-III at screening.
* Clinically stable and on optimized doses and unchanged drug classes of guideline-directed HF therapy = 30 days prior to randomization.
* Left ventricular ejection fraction (LVEF) less than (<) 50 percent (%) as assessed by echocardiography at screening, measured by central laboratory.
* Left ventricular mass indexed to body surface area (LVMi) greater than (>) 88 gram per meter square (g/m^2) for female participants and >102 g/m^2 for male participants as assessed by echocardiography at screening, using the truncated ellipsoid method measured by central laboratory.
* Left atrial volume indexed to body surface area (LAVi) = 29 milliliter per meter square (mL/m^2) as assessed by echocardiography at screening, measured by central laboratory.
* Body mass index 18.5-40 kilogram per meter square (kg/m^2) (both inclusive) and body weight less than or equal to (=) 140 kilogram (kg). Body mass index is calculated in the electronic case report form based on height and body weight at the screening visit (visit 1).
* N-terminal pro B-type natriuretic peptide (NT-proBNP) = 300 picograms per milliliter (pg/mL); NT-proBNP =600 pg/mL if atrial fibrillation/flutter is present at time of screening, measured by central laboratory.
Minimum age
40 Years
Maximum age
84 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Estimated Glomerular Filtration Rate (eGFR) less than (<) 30 milliliter/minute/ 1.73-meter square (mL/min/1.73 m^2) at time of screening, measured by central laboratory.
* Participants with an episode of acute kidney failure or acute kidney injury, at the discretion of the investigator, within 90 days prior to randomization.
* Myocardial infarction, unstable angina pectoris or HF hospitalization within 30 days prior to screening.
* Participants receiving intravenous HF medications within 30 days prior to randomization.
* Planned coronary revascularization, pacemaker/cardioverter-defibrillator/cardiac resynchronization therapy (CRT) implantation, ablation of cardiac arrythmias or valve repair/replacement at the time of randomization.
* Stroke or transient ischemic attack within 12 months prior to randomization.
* Participants with potential disruption of the blood-brain barrier (e.g., multiple sclerosis), in the opinion of the investigator.
* Known history of severe liver disease and/or alanine aminotransferase or aspartate aminotransferase greater than (>) 2.5x upper limit of normal at screening, measured by central laboratory.
* Known genetic cause of increased cardiac mass (including likely pathogenic variants within dilated cardiomyopathy, hypertrophic cardiomyopathy and Fabry disease).
* Participants with suspected or diagnosed cardiac amyloidosis or sarcoidosis.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/07/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
23/01/2028
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
Concord Repatriation General Hospital - Cardiology - Concord
Recruitment hospital [2] 0 0
Royal Adelaide Hospital Cardiovascular Clinical Trials - Adelaide
Recruitment hospital [3] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [4] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [5] 0 0
Victorian Heart Hospital - Clayton
Recruitment hospital [6] 0 0
Fiona Stanley Hospital Cardiology - Murdoch
Recruitment postcode(s) [1] 0 0
2139 - Concord
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
5042 - Bedford Park
Recruitment postcode(s) [4] 0 0
7000 - Hobart
Recruitment postcode(s) [5] 0 0
3168 - Clayton
Recruitment postcode(s) [6] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
Czechia
State/province [1] 0 0
Brno
Country [2] 0 0
Czechia
State/province [2] 0 0
Ceske Budejovice
Country [3] 0 0
Czechia
State/province [3] 0 0
Ostrava-Poruba
Country [4] 0 0
Czechia
State/province [4] 0 0
Praha 4
Country [5] 0 0
Czechia
State/province [5] 0 0
Praha
Country [6] 0 0
Germany
State/province [6] 0 0
Berlin
Country [7] 0 0
Germany
State/province [7] 0 0
Dresden
Country [8] 0 0
Germany
State/province [8] 0 0
Essen
Country [9] 0 0
Germany
State/province [9] 0 0
Frankfurt am Main
Country [10] 0 0
Germany
State/province [10] 0 0
Halle (Saale)
Country [11] 0 0
Germany
State/province [11] 0 0
Hannover
Country [12] 0 0
Germany
State/province [12] 0 0
Heidelberg
Country [13] 0 0
Germany
State/province [13] 0 0
Kiel
Country [14] 0 0
India
State/province [14] 0 0
Delhi
Country [15] 0 0
India
State/province [15] 0 0
Gujarat
Country [16] 0 0
India
State/province [16] 0 0
Kerala
Country [17] 0 0
India
State/province [17] 0 0
Maharashtra
Country [18] 0 0
India
State/province [18] 0 0
New Delhi
Country [19] 0 0
India
State/province [19] 0 0
Punjab
Country [20] 0 0
India
State/province [20] 0 0
Uttarakhand
Country [21] 0 0
Japan
State/province [21] 0 0
Bunkyo-ku, Tokyo
Country [22] 0 0
Japan
State/province [22] 0 0
Himeji-shi, Hyogo
Country [23] 0 0
Japan
State/province [23] 0 0
Ibaraki
Country [24] 0 0
Japan
State/province [24] 0 0
Kanagawa
Country [25] 0 0
Japan
State/province [25] 0 0
Kita-gun, Kagawa
Country [26] 0 0
Japan
State/province [26] 0 0
Kobe-shi, Hyogo
Country [27] 0 0
Japan
State/province [27] 0 0
Osaka-shi, Osaka
Country [28] 0 0
Japan
State/province [28] 0 0
Osaka-Shi, Osaka
Country [29] 0 0
Japan
State/province [29] 0 0
Osaka
Country [30] 0 0
Japan
State/province [30] 0 0
Sapporo-shi, Hokkaido
Country [31] 0 0
Japan
State/province [31] 0 0
Yokohama-shi, Kanagawa
Country [32] 0 0
Korea, Republic of
State/province [32] 0 0
Cheongju
Country [33] 0 0
Korea, Republic of
State/province [33] 0 0
Daegu
Country [34] 0 0
Korea, Republic of
State/province [34] 0 0
Gangwon-do
Country [35] 0 0
Korea, Republic of
State/province [35] 0 0
Seongnam-si, Gyeonggi-do
Country [36] 0 0
Korea, Republic of
State/province [36] 0 0
Seoul
Country [37] 0 0
Netherlands
State/province [37] 0 0
Amsterdam
Country [38] 0 0
Netherlands
State/province [38] 0 0
Heerlen
Country [39] 0 0
Netherlands
State/province [39] 0 0
Nijmegen
Country [40] 0 0
Netherlands
State/province [40] 0 0
Rotterdam
Country [41] 0 0
Netherlands
State/province [41] 0 0
Venlo
Country [42] 0 0
Poland
State/province [42] 0 0
Dolnoslaskie
Country [43] 0 0
Poland
State/province [43] 0 0
Podlaskie
Country [44] 0 0
Poland
State/province [44] 0 0
Biala Podlaska
Country [45] 0 0
Poland
State/province [45] 0 0
Bielsko-Biala
Country [46] 0 0
Poland
State/province [46] 0 0
Krakow
Country [47] 0 0
Poland
State/province [47] 0 0
Kraków
Country [48] 0 0
Poland
State/province [48] 0 0
Lublin
Country [49] 0 0
Poland
State/province [49] 0 0
Przemysl
Country [50] 0 0
Poland
State/province [50] 0 0
Warsaw
Country [51] 0 0
Poland
State/province [51] 0 0
Wroclaw
Country [52] 0 0
Spain
State/province [52] 0 0
Andalucía
Country [53] 0 0
Spain
State/province [53] 0 0
Cataluña
Country [54] 0 0
Spain
State/province [54] 0 0
Murcia
Country [55] 0 0
Spain
State/province [55] 0 0
Barcelona
Country [56] 0 0
Spain
State/province [56] 0 0
Dénia
Country [57] 0 0
Spain
State/province [57] 0 0
El Palmar
Country [58] 0 0
Spain
State/province [58] 0 0
Las Palmas de Gran Canaria
Country [59] 0 0
Spain
State/province [59] 0 0
Madrid
Country [60] 0 0
Spain
State/province [60] 0 0
Malaga
Country [61] 0 0
Spain
State/province [61] 0 0
Sevilla
Country [62] 0 0
Spain
State/province [62] 0 0
Valencia
Country [63] 0 0
United Kingdom
State/province [63] 0 0
High Wycombe
Country [64] 0 0
United Kingdom
State/province [64] 0 0
London
Country [65] 0 0
United Kingdom
State/province [65] 0 0
Middlesbrough

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novo Nordisk A/S
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Transparency (dept. 2834)
Address 0 0
Novo Nordisk A/S
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Novo Nordisk
Address 0 0
Country 0 0
Phone 0 0
(+1) 866-867-7178
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://novonordisk-trials.com


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06979375